Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. for the years 2020 to 2022.

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Agency IQ

JULY 13, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUL 10, 2023 10:02 AM CDT As of FY2023, the FDA has five user fee programs applicable to its life sciences portfolio: PDUFA (for non-generic prescription drugs and certain biologics), MDUFA (for medical devices), GDUFA (for generics), BsUFA (for biosimilars), and OMUFA (for over-the-counter monograph products).

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The Pharma Data

DECEMBER 13, 2020

On December17 ,2018, Toripalimab obtained conditional approval from the NMPA, for the 2 nd line treatment of patients with unresectable or metastatic melanoma. The world’s first-in-human, first-in-class BTLA blocking antibody for solid tumors is currently in phase I clinical trials in the US and China.

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The Pharma Data

JANUARY 24, 2021

Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial).

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Agency IQ

JUNE 29, 2023

The notice specifically made mention of a 2018 draft guidance document, Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements, and noted that “it is not fully understood how consumers will interpret specific quantitative claims.”

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The Pharma Data

MAY 15, 2023

Before joining Lufthansa, he served as Group CFO at Barry Callebaut based in Switzerland from 2018 through 2020. Find out more at [link] About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Prior to that, he worked in multiple executive business and finance roles for Philips and KPMG.

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Agency IQ

OCTOBER 6, 2023

This is a significant jump from any previous year, with the former peak at 15 in FY 2018, followed by several years in the 10-14 range. For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules.

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The Pharma Data

DECEMBER 27, 2020

This year has been difficult, but it has reinforced the importance of our mission: to treat and potentially even reverse the effects of serious diseases and conditions by advancing our novel cell therapy product candidates through clinical trials and into the hands of physicians.

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The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

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The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

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FDA Law Blog: Biosimilars

JANUARY 15, 2024

FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data. While FDA did try to suggest that these studies were not a requirement, the Court cited a PMTA checklist in FDA’s Decisions Document that included a requirement for a randomized controlled trial or a longitudinal cohort study.

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The Pharma Data

AUGUST 1, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $674 Million; Global Rinvoq Net Revenues Were $378 Million – Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.816 Billion, an Increase of 14.1 percent on an operational basis, due to biosimilar competition.

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The Pharma Data

APRIL 7, 2023

” These sNDAs are supported by results from the PHAROS trial (NCT03915951), an open-label, multicenter, non-randomized, Phase 2 study (n=98) to determine the safety, tolerability, and efficacy of BRAFTOVI given in combination with MEKTOVI in patients with BRAF V600E-mutant metastatic NSCLC. Ono Pharmaceutical Co.

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The Pharma Data

JULY 8, 2021

“By combining the expertise of the healthcare industry and the non-profit research community, we can carefully assess how biomedical data at this unprecedented scale is best utilized and hopefully accelerate the path from genetic discoveries towards novel therapeutics.”.

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The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5 Recorded a $4.7

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Production International Clinical Trials Small Molecule 52

The Pharma Data

FEBRUARY 8, 2021

We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks. price, patients switching to Toujeo ® and biosimilar glargine competition. driven by Rest of the World sales growth which more than offset biosimilar competition in Europe. Plavix ® sales were down 1.4%

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The Pharma Data

FEBRUARY 4, 2021

We continue to work in parallel on our two COVID-19 vaccine candidates, with clinical trials starting in the coming weeks. price, patients switching to Toujeo ® and biosimilar glargine competition. driven by Rest of the World sales growth which more than offset biosimilar competition in Europe. Plavix ® sales were down 1.4%

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Vaccine Production FDA Pharmaceuticals 52

The Pharma Data

APRIL 27, 2021

reflecting increased competition partially offset by demand growth partly related to clinical trial supply and price upside in Europe. net price, increasing usage of Toujeo ® , biosimilar glargine competition and lower sales in Europe (patient stockpilling in the first quarter of 2020). Aubagio ® sales decreased 1.1% In the U.S.,

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The Pharma Data

APRIL 11, 2021

This data will be presented in a Clinical Trials Plenary Session on April 10 at the virtual American Association for Cancer Research (AACR) Annual Meeting 2021 and simultaneously published in The Lancet Oncology. Of the relapsed iNHL patients included in the trial, 60% had FL, 20.7% Abstract: CT001. versus 47.7% MZL, 10.9%

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The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. The FDA action converts the 2018 accelerated approval to full approval. Inlyta globally, up 34% operationally, primarily reflecting increased demand in the U.S.

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Vaccine Production FDA Biosimilars 40

Drug Discovery World

JULY 26, 2024

The strategy is aimed at keeping the sector competitive in a country that has recently been struggling to maintain relevance in the global medical device and clinical trials scenes. Conversely, Trump champions free market competition and biosimilars. Meanwhile, new cell therapies are showing promise in oncology.

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